Short-Term Clinical Outcome of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing

Arthropathy of Hip Clinical Trial

Official title:

Short-Term Clinical Outcome Including Dislocation Rate and Ceramic Fracture of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103882
• Other study ID #: INT.CR.LKR1.10
• Status: Completed
• Start date: May 2010
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objectives of this clinical study include:

• Assess the rate of dislocation and fracture of THA using the new (the 4th generation) ceramic implants.

• Evaluate the survival rate of THA using the new alumina-zirconia (the 4th generation) composite ceramic bearing.

• Investigate the performance of the 4th generation ceramic implants mostly in patients younger than 50 years.

• Compare the preoperative and postoperative scores of Harris Hip Score, UCLA Activity Score and WOMAC.

Description:

This study will evaluate incidence of dislocation and short-term clinical outcome on patients who undergo large diameter 4th generation ceramic bearing total hip Arthroplasty ("THA") in comparison to historical data on 3rd generation CoC THA (28mm) patients. Specifically the study intends to address the following research topics:

1. The incidence of dislocation after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing.

2. The incidence of ceramic fracture after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing

3. The survival rate, wear rate, and incidence of osteolysis of THA with use of the 4th generation Ceramic Bearing

4. Range of motion improvement from preoperative to postoperative to support Korean sitting style after THA with use of the 4th generation Ceramic Bearing.

5. Clinical outcomes, activity level and QoL of patients with use of the 4th generation Ceramic Bearing.

6. The performance of THA with use of the new ceramic bearing mostly in patients younger than 50 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: December 2017
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients suitable for primary Total Hip Replacement

• Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:

1. Osteoarthritis

2. Avascular necrosis

3. Legg Perthes

4. Rheumatoid Arthritis

5. Diastrophic variant

6. Fracture of the pelvis

7. Fused hip

8. Slipped capital epiphysis

9. Subcapital fractures

10. Traumatic arthritis

• Patients aged over 20

• Patients must be able to understand instructions and be willing to return for follow-up

Exclusion Criteria:

• Absolute contraindications include: infection, sepsis, and osteomyelitis

• Relative contraindications include:

1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,

2. osteoporosis,

3. metabolic disorders which may impair bone formation,

4. osteomalacia,

5. distant foci of infections which may spread to the implant site,

6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and

7. vascular insufficiency, muscular atrophy, or neuromuscular disease.

8. pregnancy

Related Conditions & MeSH terms

• Arthropathy of Hip
• Joint Diseases

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Hospital	Anyang
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Murup Hospital	Masan
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dislocation	Number of dislocations	12 month postop
Secondary	Clinical Outcomes	Harris Hip Score, UCLA and WOMAC	12 months, 18 months and 30 months